Traditional Knowledge and Intellectual Property Rights

In all cultures around the globe, including western ones, thousands of years of plant use is taking place. The knowledge of how to use and prepare plants for food, shelter, medicine and beauty has been passed down from generation to generation by word of mouth, thoughtful guidance and notation. Traditional knowledge is also stored in thousands of family cookbooks, doctor’s manuals, medical, herbal and therapeutic manuscripts, official national pharmacopoeias, clinical journals and the worldwide web. Plant raw materials are used daily in every part of the world as foods, food supplements, cosmetics and medicines. Such products have financial targets, marketing, investment, R & D, manufacturing and product compliance standards to meet. So understandably, such time, money and effort is often protected by intellectual property rights (IPR). However traditional systems of medicine are a summation of several thousands of years of human experience in the selection of plants for preventive and curative healthcare, so how can this knowledge be owned? Even today 80% of the population in Asia and Africa still rely on traditional medicine as their primary form of healthcare and 25% of pharmaceutical substances are derived from plants (WHO 2008). Approximately 52,000 species of plants are used for medicinal purposes worldwide (8-15% of which may die out due to over exploitation) (Schippman et al). The UN Declaration of the Rights of Indigenous People states that indigenous peoples have the right to maintain, control and protect and develop their cultural heritage and traditional knowledge (UN 2007). However traditional knowledge and its application in intellectual property law is complex, largely due to the size and diversity of such knowledge. Protecting it in a legal context must factor in issues such as: defining and describing of what requires protection; identification of the owners or custodians of such knowledge; establishing the nature; scope and duration of protection rights, and what the role of national and international agencies in recognising and formalising such rights should be (Anderson 2010).

Intellectual Property Rights (IPR) are defined as legal ownership of inventions, commercial designs and pharmaceutical technologies. IPR can include: trademarks, patents, copyrights and trade secrets. The strongest form of Intellectual property protection is the patent, it infers ownership for at least 20 years (IPO). Patents can only be granted on novel inventions with industrial or pharmaceutical applications, there must be no prior art (any evidence that the invention is already known) (EPO), however if the patent goes undisputed it can be granted because nobody has officially stated or been aware that there is prior art on the patent.

Norman Heatly and Ernst Chain managed to prove the medicinal application of penicillin in 1940, however it was an American who patented this first anti-biotic, which went on to save thousands of soldiers life’s during WWII. The position of the UK Medical Research Council at the time was that it was distasteful for scientists to profit from their work and UK law did not allow the patenting of chemicals and medicines. Across the pond, American pharmaceutical companies patented many drugs during the 1950s and 60s. The Association of the British Pharmaceutical Industry (ABPI) lobbied the UK government, which resulted in the Patents Act 1946, allowing the patenting of chemical substances. In 1978 the European Patent Convention came into effect; this pharmaceutical-patent paradigm is now entrenched into the EU patent systems. The Italians resisted only to be sued by large pharmaceuticals, resulting in their own patent laws being overturned in 1978; it led to a massive reduction in Italian drug exports and innovation and today most pharmaceuticals are imported into Italy. The Indian Patent Act 1970 prohibited the patenting of chemicals and medicines, and as a result the Indian pharmaceutical industry flourished by making affordable generic drug copies for the Indian population. India had to sign the Agreement on Trade Related Aspects of Intellectual Property (TRIPS) in 1995 as required under the World Trade Agreement by all member states. TRIPS embodies the pharmaceutical-patent paradigm (Palombi 2005). However in 2009 the Indians, who are oft dubbed ‘the pharmacy to the 3rd world’, denied two American companies’ Aids drugs patents in favour of the Indian Pharmaceutical giant, Cipla (ANI 2009). India’s Council of Scientific and Industrial Research (CSIR) have now set up The Traditional Knowledge Digital Library (TKDL) to protect India’s four main traditional knowledge systems: Ayurveda, Unani, Siddha and Yoga. The TKDL provides hundreds of documents of prior art info to patent researchers. It is not open to the public, permission must be sought to access, thus further protecting India’s traditional knowledge. The TKDL was used successfully to revoke a patent granted for the ancient Ayurvedic herb, turmeric, for wound healing (Hindustan Times 2013).

The World Intellectual Property Organization (WIPO) is aware that traditional knowledge requires protection for both cultural and local economic reasons. WIPO is currently in negotiations to develop an international legal instrument to protect traditional knowledge, be that cultural or medicinal. There are various ways traditional knowledge can be protected, such as trademarking, however this does not prevent a new trademark name for the same herb from being registered. Geographical origin protection is also possible, but plants often naturally span very large geographical areas. Establishing official stores of prior art traditional knowledge is also viable. The Thai government have lead the way and employed a Sui generis approach (unique, cannot be compared) through the Thai Protection and Promotion of Traditional Thai Medicinal Intelligence Act 1999, which protects traditional formulas and knowledge holders to an extent. However the Thai Department of intellectual property, which has been gathering such knowledge, has left it openly accessible, which in itself presents a challenge in terms of protecting such knowledge (Kudngaongarm 2011).

The other major complicating factor is who are traditional knowledge holders and how can their ‘ownership’ be established, especially in the West where the practice of herbal medicine is not actually even legal in many EU countries. Many plants are used by numerous different traditional practitioners across the globe. For example, the herb motherwort (Leonurus cardiaca) is used by TCM, Ayurvedic and western medical herbalists for grief, anxiety, menopause and post pregnancy. Nicholas Culpeper (pharmacist and author of The Complete Herbal 1653) wrote of motherwort “There is no better herb to drive melancholy vapours from the heart”. A search of the World Intellectual Property Organisation (WIPO) patent database shows a 2007 patent application for the use of Leonurus cardiaca as an anti-arrhythmic agent in cases of heart disease. However due to prior art it has not been granted. Crucially, because patents have to be novel, this also prevents traditional knowledge holders from protecting herbs with patents. There are numerous examples of patents for methods of isolating chemical constituents from plants, such as Leonurine a key isolated constituent of Leonurus cardiaca, and we found one patent application for leonurine as an anti-arrhythmic agent. The method of isolating a key constituent of a plant and applying it therapeutically can be patented, as it is much more likely to be novel, and therefore it is commercially viable to isolate chemicals from plants and evaluate them scientifically. A key argument for the lack of evidence for the efficacy of traditional medicinal plants and practice, which by law discounts all empirical evidence even if it is continuous across a thousand years, is that there is not enough robust scientific research to back it up. The shape of patent law is a major factor as to why. Even if traditional knowledge were protected with patents, it does not make them commercially viable and ‘traditional’ medicinal holders are a diverse and often undefinable group. Identifying the custodians of traditional knowledge and establishing collections of traditional knowledge as ‘prior art’ is certainly however a starting point.